Senior Clinical Research Associate

Company Description

Cutera, Inc. is a leading aesthetics device company with a comprehensive product portfolio and a worldwide distribution footprint. The Company’s technology enables physicians to provide sophisticated solutions for a wide range of medical aesthetic applications. We are looking for a key member to join our fast-paced R&D engineering team in changing the landscape of medical aesthetics.

Please visit www.cutera.com for more information about us!

Job Description

Position Summary:

We are seeking a Senior Clinical Research Associate to join our clinical team in its mission to improve lives through medical aesthetic technologies driven by science​. Our products use a broad range of innovative laser and radio frequency technologies designed by our scientists and engineers to enable first-to-market applications and best-in-class products for dermatology.

Reporting to the Director of Clinical Research, the Senior CRA is responsible for leading and coordinating activities among participating study physicians and maintaining study records. Serving as the primary point of contact for study sites, this role oversees the organization and execution of pre- and post-market clinical research studies. The Senior CRA collaborates with research staff to uphold best practices, ensuring study integrity and accurate data documentation. Additionally, you will establish and maintain relationships with investigators, site coordinators, and regulatory personnel, ensuring compliance with GCP guidelines and all relevant clinical study regulations.

Duties & Responsibilities:

• Lead the development, production and compilation of study documents such as protocol, case report forms (paper or electronic), informed consent, subject questionnaire, clinical study reports, clinical portions of applicable regulatory submissions, IRB submission, data management or statistical analysis plans or other controlled documentation.
• Perform site qualification, study initiation, site training, interim monitoring and study close-out visits, and complete timely and accurate site visit reports.
• Design forms (electronic or paper based) for receiving, processing, or tracking data.
• Develop and maintain study and data tracking tools and report study/ data metrics to supervisory staff.
• Track and ensure the timely flow of study documentation and case report forms, including in-house data flow and/or electronic forms transfer.
• Monitor data -- remotely, on site, and via other approved modes – with a focus on data integrity (completeness, accuracy, consistency, timeliness) and patient safety.
• Create and manage clinical databases and process clinical data, including receipt, entry, verification, or filing of information.
• Prepare data analysis listings and activity, performance, or progress reports.
• Generate data queries and liaise with the study sites to resolve identified problems in a timely manner.
• Prepare and maintain the study essential documents including sponsor and site-specific regulatory documentation (binders or eTMF)
• Write work instruction manuals, data capture guidelines, and other study specific standard operating procedures.
• Consistently assess processes, systems, and technologies for efficiency and compliance with procedures; suggest revision to increase productivity as applicable.
• Analyze clinical data using appropriate statistical tools
• Help record and track clinical trial data on online government databases. (www.clinicaltrials.gov)
• Help select specific software programs for various research procedures and scenarios as needed.
• Train staff on study procedures, photography and software program usage.
• Provide support and information to functional areas such as clinical affairs, regulatory, research & development and marketing.
• Ensure study documentation, procedures, data collection and analysis are conducted in accordance with Cutera SOPs, FDA regulations, ICH Good Clinical Practice (GCP) guidelines and other applicable regulations.
• Other duties as assigned.

Qualifications

Minimum Requirements & Qualifications: 

• B.Sc. in the life sciences or allied health/medical related field, or equivalent experience.
• 3+ years of experience in a clinical research environment preferred.
• Experience independently running a study from start-up through close-out required.
• Experience in the medical device and/or dermatology or aesthetic space preferred.
• Knowledge of GCP guidelines, medical terminology and clinical trial processes required.
• Proficient in the use of Microsoft Office Applications (Word, Excel, PowerPoint, etc.)
• Working knowledge of EDC, eTMF and/or other clinical